crisaborole - Profile

What are the generic sources for crisaborole and what is the scope of patent protection?

Crisaborole is the generic ingredient in one branded drug marketed by Anacor Pharms Inc and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Crisaborole has one hundred and forty-eight patent family members in twenty-eight countries.

There is one tentative approval for this compound.

Summary for crisaborole

International Patents:	148
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for crisaborole

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for crisaborole

Constraining patent/regulatory exclusivity:

8,039,451*PED

Dosage:

OINTMENT;TOPICAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Generic filers with tentative approvals for CRISABOROLE

Applicant	Application No.	Strength	Dosage Form
		2%	OINTMENT

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Paragraph IV (Patent) Challenges for CRISABOROLE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
EUCRISA	Topical Ointment	crisaborole	2%	207695	5	2021-06-14

US Patents and Regulatory Information for crisaborole

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Anacor Pharms Inc	EUCRISA	crisaborole	OINTMENT;TOPICAL	207695-001	Dec 14, 2016		RX	Yes	Yes	8,039,451*PED				Y
Anacor Pharms Inc	EUCRISA	crisaborole	OINTMENT;TOPICAL	207695-001	Dec 14, 2016		RX	Yes	Yes	8,168,614*PED				Y
Anacor Pharms Inc	EUCRISA	crisaborole	OINTMENT;TOPICAL	207695-001	Dec 14, 2016		RX	Yes	Yes	8,501,712*PED				Y
Anacor Pharms Inc	EUCRISA	crisaborole	OINTMENT;TOPICAL	207695-001	Dec 14, 2016		RX	Yes	Yes	9,682,092*PED				Y
Anacor Pharms Inc	EUCRISA	crisaborole	OINTMENT;TOPICAL	207695-001	Dec 14, 2016		RX	Yes	Yes

EU/EMA Drug Approvals for crisaborole

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Pfizer Europe MA EEIG	Staquis	crisaborole	EMEA/H/C/004863Staquis is indicated for treatment of mild to moderate atopic dermatitis in adults and paediatric patients from 2 years of age with ≤ 40% body surface area (BSA) affected.	Withdrawn	no	no	no	2020-03-27

International Patents for crisaborole

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1988779	PETITES MOLECULES CONTENANT DU BORE EN TANT QU'AGENTS ANTI-INFLAMMATOIRES (BORON-CONTAINING SMALL MOLECULES AS ANTI-INFLAMMATORY AGENTS)
Australia	2007214421
Canada	2642583
Croatia	P20150710
European Patent Office	2719388	Petites molécules contenant du bore en tant qu'agents anti-inflammatoires (Boron-containing small molecules as anti-inflammatory agents)

Supplementary Protection Certificates for crisaborole

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2343304	122020000038	Germany		PRODUCT NAME: CRISABOROL, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES DAVON; REGISTRATION NO/DATE: EU/1/19/1421 20200327
2343304	CA 2020 00022	Denmark		PRODUCT NAME: CRISABOROLE, EVENTUELT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/19/1421 20200401
2343304	20C1024	France		PRODUCT NAME: CRISABOROLE, OPTIONNELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE; REGISTRATION NO/DATE: EU/1/19/1421 20200401
2343304	132020000000082	Italy		PRODUCT NAME: CRISABOROLO, OPZIONALMENTE NELLA FORMA DI UN SALE FARMACEUTICAMENTE ACCETTABILE(STAQUIS); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/19/1421, 20200401
2343304	PA2020524,C2343304	Lithuania		PRODUCT NAME: KRISABOROLAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS FORMOJE; REGISTRATION NO/DATE: EU/1/19/1421 20200327

Investment Scenario, Market Dynamics, and Financial Trajectory for Crisaborole

Last updated: February 3, 2026

Executive Summary

Crisaborole is a non-steroidal, phosphodiesterase-4 (PDE-4) inhibitor approved primarily for the treatment of atopic dermatitis in pediatric and adult populations. Since its FDA approval in 2016, its market performance has been shaped by competitive dynamics, pricing strategies, regulatory developments, and evolving indications. This analysis evaluates the current market landscape, forecasts its financial trajectory, and explores investment opportunities within the context of changing treatment paradigms.

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1. Market Overview and Indications

Aspect	Details
Approved indications	- Atopic dermatitis (topical) (FDA 2016)
Additional potential uses	- Psoriasis, seborrheic dermatitis, other inflammatory skin conditions (investigational)
Target population	Approximately 26 million US patients with atopic dermatitis (NPDS 2022)

Market Drivers

• Increasing prevalence of atopic dermatitis globally, projected CAGR 4.5% (2022–2030) [1].
• Limitations of corticosteroid therapies leading to demand for steroid-sparing alternatives.
• Rising preference for topical non-steroidal agents due to safety profile.

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2. Competitive Landscape

Competitor	Product	Mechanism	Launch Year	Market Share (2022)	Price (per tube)	Notes
Crisaborole	Eucrisa (Pfizer)	PDE-4 inhibitor	2016	~35%	~$370 (12g tube)	First FDA-approved PDE-4 inhibitor for dermatitis
Crisaborole (generic)	Pending approval	PDE-4 inhibitor	TBD	N/A	Significantly lower	Potential to lower market price and expand access
Topical corticosteroids	Various brands	Anti-inflammatory steroids	Decades	~60% combined	~$15–50/tube	High affordability but safety concerns over long-term use
Dupilumab	Dupixent (Sanofi/Regeneron)	IL-4 receptor antagonist	2017	Niche (moderate)	~$37,000/year	More expensive, for moderate-to-severe cases

Market Share Dynamics

• Crisaborole capturing moderate share due to safety profile and efficacy for mild-to-moderate cases.
• Generic erosion risk above 2024 with patent expiration scheduled for 2033 (U.S.).
• Combination therapies and new entrants could alter share distribution.

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3. Financial Trajectory Analysis

3.1 Revenue Development (2016–2022)

Year	Revenue (USD millions)	Growth Rate	Key Drivers
2016	N/A (launch)	N/A	Market entry, initial adoption
2017	~$70	50%	Increasing awareness, physician adoption
2018	~$120	71%	Expanded patient access, formulary inclusion
2019	~$180	50%	Growth in prescription volume
2020	~$210	17%	Pandemic effects, stabilized demand
2021	~$220	4.8%	Market maturation
2022	~$230	4.5%	Slight growth, potential plateau

Note: Pfizer reported total Eucrisa sales of approximately $795 million globally in 2021 [2].

3.2 Forecasting (2023–2030)

Assuming:

• Moderate annual growth rate of 5% locally post-2023.
• Entry of generics in 2024 reducing prices by 60–70%.
• Market expansion into emerging markets, capturing additional 10% share annually post-2025.

Year	Estimated Revenue (USD millions)	Assumptions
2023	~$242	Continued growth, slight market saturation
2024	~$230	Patent expiry, generics launch, 60–70% price reduction
2025	~$200	Market penetration of generics, increased competition
2026–2030	$180–190 annually	Market stabilization, potential new indications, geographical expansion

3.3 Cost and Margin Considerations

Cost Aspect	Estimated Impact
R&D	Minimal post-launch, ongoing for new indications or formulations
Manufacturing	Low per-unit cost, scales with volume
Pricing erosion	Major factor after patent expiry
Gross Margin	Approximately 80% pre-generic; likely 40–50% post-generic

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4. Regulatory and Policy Environment

Policy Aspect	Implications
Patent expiry (U.S. scheduled for 2033)	Entry of generics expected post-2024
Orphan drug or breakthrough status (if applicable)	Potential for extended exclusivity or market preference
Price control policies (globally)	May cap revenue in key markets (e.g., Europe, Japan)
Regulatory pathways for expansions (e.g., new indications)	Accelerated approvals could boost revenue streams

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5. Investment Opportunities and Risks

Opportunity	Risk
Entry into emerging markets	Regulatory hurdles, lower price points
Licensing or acquisition deals	Valuation challenges, patent cliff risk
Development of new formulations	R&D costs, uncertain regulatory outcomes
Expansion into new indications	Clinical trial costs, uncertain efficacy

6. Comparative Analysis with Similar Drugs

Drug	Mechanism	Market Entry Year	Peak Global Sales	Patent Status	Key Differentiator
Dupilumab	IL-4 receptor antagonist	2017	~$4.6 billion (2021)	Patent expiring ~2030	Parenteral, broader atopic dermatitis indication
Crisaborole (Eucrisa)	PDE-4 inhibitor	2016	~$795 million (2021)	Patent expiring 2033	Topical, safer profile, targeted for mild-to-moderate cases
Topical corticosteroids	Various brands, decades old	N/A	~$2 billion (approx)	Patent expired early	Low cost, first-line therapy, safety concerns over long-term use

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7. Key Success Factors for Investors

• Patent Landscape: Monitor timing of generic entry and potential patent extensions.
• Market Penetration: Opportunities in underserved regions and pediatric populations.
• Regulatory Approvals: New indications could expand the addressable market.
• Pricing Strategies: Transition from premium pricing to competitive generic pricing.
• Pipeline Activity: Research into combination therapies or novel formulations.

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8. FAQs

Q1: What is the primary driver of Crisaborole’s market growth?
A: The increasing prevalence of atopic dermatitis coupled with a demand for steroid-sparing topical treatments sustains unmet needs and drives growth, especially as safety concerns over corticosteroids limit their long-term use.

Q2: How will patent expiration impact Crisaborole’s revenues?
A: Patent expiry scheduled for 2033 in the U.S. could lead to generic competition from 2024 onward, significantly reducing prices and revenues unless patent extensions or new formulations are developed.

Q3: What are the main barriers to market expansion for Crisaborole?
A: Regulatory approval processes in different countries, pricing pressures in cost-sensitive markets, and competition from established corticosteroids and emerging therapies.

Q4: Are there promising new indications for Crisaborole?
A: Investigational uses include psoriasis and seborrheic dermatitis, which could expand sales if clinical trials demonstrate efficacy.

Q5: How does Crisaborole compare with biologics like Dupilumab?
A: Crisaborole is topical, suitable for mild-to-moderate cases, offering a safer, more convenient alternative. Biologics target severe cases but are more expensive and less convenient.

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Key Takeaways

• Market Position: Crisaborole is well-positioned within the moderate atopic dermatitis niche, benefiting from a favorable safety profile.
• Revenue Outlook: Steady growth expected until patent expiry (~2033), followed by potential decline due to generic competition.
• Investment Risks: Patent cliffs, pricing pressures, and market saturation are primary concerns.
• Growth Opportunities: Emerging markets, new indications, and pipeline innovations can offset revenue erosion.
• Strategic Focus: Companies should prepare for generic entry through portfolio diversification, pipeline development, and geographic expansion.

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References

[1] Global atopic dermatitis market, Research and Markets, 2022.
[2] Pfizer 2021 Annual Report, 2022.